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Arthritis Rheum:利妥昔单抗对肝炎病毒感染的相关血管炎有效

来源:医学论坛网 2012-01-18 11:29

最近,由美国国立卫生研究院(NIH)赞助的一项研究"A randomized controlled trial of rituximab following failure of antiviral therapy for hepatitis C-associated cryoglobulinemic vasculitis"显示:对于抗病毒治疗未解缓的与丙型肝炎病毒(HCV)感染相关的冷球蛋白血症性血管炎(CV)患者,利妥昔单抗治疗有效且耐受性良好。相关研究结论于2011年12月6日在线发布于《关节炎与风湿病》Arthritis Rheum杂志。

该项研究为开放性、单中心随机对照试验,研究人员在抗病毒治疗未解缓的HCV感染相关的CV患者中将利妥昔单抗【每周375 mg/m2,共4 周】与HCV感染相关CV的最有效疗法(Best available therapy)进行了比较,主要终点是进入研究后6个月的缓解率。

结果:共有24例患者被纳入研究,两组患者基线时的疾病活动度及器官受累相似;研究6个月时,利妥昔单抗组10例(83%)患者缓解,对照组1例(8%)患者缓解,该结果达到了停止研究的标准(P<0.001);达到主要终点时,利妥昔单抗治疗患者的中位缓解持续时间为7个月;研究中,未观察到利妥昔单抗对HCV血浆病毒血症或肝转氨酶水平的不良反应。(生物谷Bioon.com)

A randomized controlled trial of rituximab following failure of antiviral therapy for hepatitis C-associated cryoglobulinemic vasculitis.

Sneller MC, Hu Z, Langford CA.

OBJECTIVES:

To report on the results of a randomized controlled trial of rituximab in hepatitis C virus (HCV)-associated mixed cryoglobulinemic vasculitis.

METHODS:

We conducted an open-label single center randomized controlled trial of rituximab (375 mg/m(2) per week for 4 weeks) compared to best available therapy for treatment of patients with HCV-associated cryoglobulinemic vasculitis in whom antiviral therapy failed to induce remission. The primary endpoint was remission at 6 months from study entry.

RESULTS:

A total of 24 patients were enrolled. Baseline disease activity and organ involvement were similar in the two groups. Ten patients in the rituximab group (83%) were in remission at study month 6, compared with 1 patient in the control group (8%), a result that met criterion for stopping the study (P<0.001). The median duration of remission for rituximab-treated patients reaching the primary endpoint was 7 months. No adverse effect of rituximab on HCV plasma viremia or hepatic transaminase levels was observed.

CONCLUSIONS:

Therapy with rituximab was well tolerated and effective treatment for patients with HCV-associated cryoglobulinemic vasculitis in whom antiviral therapy fails to induce remission.

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